Post on 05-Jul-2018
Dr Herbert SCHNEIDER AGRIVET International Namibia
Chairman : OIE ad hoc Group on Veterinary Services
The impact of Good Veterinary Services Governance (GVSG) on the control over Veterinary Medicinal Products (VMP´s)
The evaluation of Good Veterinary Governance with the OIE Performance of Veterinary Services
Tool (PVS) with specific reference to Veterinary Medicinal Products.
AGRIVET
Namibia
Recent emergence and re-emergence of transboundary animal diseases,
Good Veterinary Services Governance
GVS
G new risks arising from global warming or globalization
the estimate that 75% of emerging (new) diseases and 80% of pathogenic agents having a potential use in bioterrorist activities are zoonotic
demonstrate the need for Good Veterinary Services Governance (GVSG) on a global, regional and national scale
AGRIVET
Namibia
Global Public Good
GVS
G
The role of Veterinary Services in animal health, specifically in the prevention, control and eradication of animal diseases, as well as having a crucial function in public health and zoonoses control, Veterinary Services (VS) clearly constitute a global public good.
AGRIVET
Namibia
Global Public Good
GVS
G
A global public good is
• non-rivalous. Consumption of this good by anyone does not reduce the quantity available to other agents.
• non-excludable.It is impossible to prevent anyone from consuming that good.
• available worldwide.
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Namibia
One World – One Health
GVS
G
The strategy of “One World – One Health”, relating to the prevention and control of emerging infectious
diseases at the animal/human interface such as those with the potential to cause epidemics and pandemics, but also those animal diseases having an impact on food security and poverty, depends on GVSG on all
respective levels of activity and service delivery
AGRIVET
Namibia
GVSG and VMP´s
GVS
G
An essential cornerstone and tool in addressing and sustaining GVSG are veterinary medicinal products (VMP´s), such as veterinary drugs (medicines) and biologicals
A consolidated legislative framework, establishing mandate and responsibilities of the VS, supported by adequate human, physical and financial resources, are integral and essential components for the control of VMP´s, executed in a public-private partnership with all stakeholders such as the pharmaceutical industry, private veterinary sector and animal (livestock) owners.
AGRIVET
Namibia
which areOfficial references of the WTO SPS AgreementAdopted by consensus of OIE Members
and are available as theTerrestrial Animal Health Code (TAHC)
OIE
Inte
rnat
iona
l Sta
ndar
ds The Quality of Veterinary Services (VS)depend on
OIE International Standards
AGRIVET
Namibia
OIE
Cod
e The TAHC
Terrestrial Animal Health Code (TAHC) mammals, birds and bees available at http://www.oie.int/eng/normes/mcode/ en_sommaire.htm
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OIE
Cod
e
Chapter 3.1. - Veterinary Services Chapter 3.2. - Evaluation of Veterinary Services Chapter 6.10. - Responsible & Prudent use of
Antimicrobial Agents in Vet. Med
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Applicable OIE reference quality standards relating to veterinary medicines and chemical residues are described in the following chapters of the Code:
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include fundamental principles of an ethical
organizational; and technical nature
and VS shall conform to these principles regardlessof the political, economic or social situation of the
respective country
Stan
dard
s on
the
Qua
lity
ofVS
Standards on the Quality of Veterinary Services (VS)
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Chapter 3.1. - Veterinary Services Article 3.1.1
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Namibia
Art. 3.2.7 – Animal and Veterinary Public Health- control over use of VMP´s
Art. 3.2.9 – Veterinary Public Health- chemical residue testing- - veterinary medicines
Art. 3.2. 14 – information requirementsArt. 6.10.6 – responsible & Prudent use of antimicrobial
agents in Veterinary Medicine
These OIE standards, contained in Chapter 3.2 & 6.10 of the 2009 TAHC,
relating to VMP´s are:
Stan
dard
s on
the
Qua
lity
ofVS
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Chapter 6.7.1 of the 2009 TAHC, relating to controlling
antimicrobial resistance
Stan
dard
s on
the
Qua
lity
ofVS
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the OIE recognizes that antimicrobial resistance is a global public and animal health concern that is influenced by the usage of antimicrobial agents in humans, animals and elsewhere
and in Chapter 6.10.6 outlines the responsibilities of veterinarians
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Chapter 6.10.6 of the TAHC
TAH
C C
hapt
er 6
.10.
6
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The concern of the veterinarian is to promote publichealth and animal health and welfare. The veterinarian’s responsibilities include preventing, identifying and treating animal diseases. The promotion of sound animal husbandry methods, hygiene procedures and vaccinationstrategies (good farming practice) can help to minimizethe need for antimicrobial use in food-producing animals.
Veterinarians should only prescribe antimicrobials for animals under their care..
AGRIVET
Namibia
Chapter 6.10.6 Responsibilities of Veterinarians
TAH
C C
hapt
er 6
.10.
6
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1. Use of antimicrobial agents2. Choosing an antimicrobial agent3. Appropriate use of the antimicrobial agent4. Recording5. Labelling6. Training.
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Namibia
The OIEPVS Evaluation Tool and its application to GVSG regarding VMP´s
ÔIE
PVS
Eval
uatio
n To
ol
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Any improvement of national veterinary services hasto be based on a systematic evaluation of theircurrent performance, and therefore to use set ofstandard evaluations through the OIE.
In order to evaluate national Veterinary Services’compliance with these OIE TAHC Standards, as wellas to assist in putting into place GVSG, the OIE hasestablished procedures for the evaluation of the VS,based on the provisions in Chapter 3.2. of the Code
AGRIVET
Namibia
Any suchEVALUATION of a VS should use
the
OIE Tool for the Evaluation of the Performance of
VS (OIE-PVS Tool)Th
e O
IEPV
S Ev
alua
tion
Tool
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Namibia
The
OIE
PVS
Eval
uatio
n To
ol Based on provisions of the TAHC Chapter 3.2 Articles 3.2.3 to 3.2.13
evaluation criteria
Article 3.2.14
detailed information
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The
OIE
PVS
Eval
uatio
n To
ol
The OIEPVS Tool is not static updated /amendedat regular intervals
based on need and field experiences
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The use of the OIE-PVS Tool
The
OIE
PVS
Eval
uatio
n To
ol
1. Self evaluation performed by internal and/or OIE experts for the purpose of assessing the performance of VS
- process reviewed on a regular basis to monitorimprovements
2. An evaluation for the purpose of risk analysis in the international trade in animals and/or animal derivedproducts to which official sanitary and/or zoosanitarycontrols apply
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3. An independent evaluation that provides a strong legitimization of a request for national and /orInternational financing. Major donors have accepted the use of the OIE PVS Tool and the criteria in the Codein the evaluation of performance and priorities of VS, as a prerequisite in helping countries make requestsfor investment.
The use of the OIE-PVS Tool
The
OIE
PVS
Eval
uatio
n To
ol
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Namibia
The
OIE
PVS
Eval
uatio
n To
ol
Human, physical and financial resources
Technical authority and capability Interactions with stakeholders Access to markets
4 Fundamental components
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AGRIVET
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e O
IEPV
SEv
alua
tion
Tool
PVS
4 Fundamental components
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IEPV
SEv
alua
tion
Tool
For each of the 4 fundamental components, 6 to 12 critical competencies
I. Technical authority and capabilityVeterinary laboratory diagnosis Laboratory quality assuranceRisk analysisQuarantine and border securityEpidemiological surveillanceEarly detection and emergency responseDisease prevention, control and eradicationVeterinary public health & food safetyVeterinary medicines & veterinary biologicalsResidue testingEmerging issuesTechnical innovation
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The
OIE
PVS
Eval
uatio
n To
ol
5 Levels of
advancement
A higher level
assumes
compliance with
all preceding
levels
Level 1no compliance
Level 5 full compliance with OIE
standards
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AGRIVET
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e O
IEPV
SEv
alua
tion
Tool
Within the 4 fundamental components of the OIE PVS Tool , the following competencies address
the control of VMP´s directly or indirectly
II. Technical authority and capabilityII.2 Laboratory Quality AssuranceII.9 Veterinary medicines & veterinary biologicalsII.10 Residue testing
III. Interaction with StakeholdersIII.2 Consultation with stakeholders
IV. Access6 to MarketsIV.1 Preparation of legislationand regulations, and implementation of regulationsIV.2 Stakeholder compliance with legislation and regulationsIV.3 International Harmonisation
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IEPV
SEv
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Tool
OIE
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II. Technical authority and capabilityThis component of the evaluation appraises the authority
and capability of the VS to develop and apply sanitary measures and science based procedures supporting these measures. It comprises twelve critical competencies.
Critical competency:
II.9 Veterinary medicines & veterinary biologicals
II.9. Veterinary medicines & veterinary biologicalsThe authority and capability of the VS to regulate
veterinary medicines and veterinary biologicals.
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Activity per Level
Level
1
The VS cannotregulate the usage of veterinarymedicinesand veterinarybiologicals.
2
The VS has onlylimited capabilityto exerciseadministrative control (includingregistration) over the usage, including import and production, of veterinarymedicines and veterinarybiologicals.
3
The VS exercisequality control (technicalstandards) over the import, production and distribution of veterinarymedicines and veterinarybiologicals.
4
The VS exercisecompletecontrol over registration, sale and usage of veterinarymedicines and veterinarybiologicals.
5
The VS implementsystems to monitor the use of veterinarymedicines, veterinarybiologicals and their side effects(pharmacovigilance).
II.9 Veterinary medicines & veterinary biologicals
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Evaluation results in numerous completed OIEPVSReports indicate critical shortcomings in legislation,administration and quality control over veterinarymedicinal products.
Con
clus
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In this context it must be kept in mind that the credibilityof the VS of a country is closely linked to its ability andperformance regarding the control and prudent use ofantimicrobials.
The control of veterinary medicinal products is thusan important and integral function and primaryresponsibility of national public VS´s, executed in apublic-private partnership with all stakeholders such asthe pharmaceutical industry, private veterinary sector andanimal (livestock) owners.